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Posted On: 10/20/2020 7:18:42 AM
Post# of 148902
Re: generactor #62095
Generactor Wrote:
Quote:Well, we are once again dealing with ambiguities in the PR.
So the added 2 weeks to the monitoring period means the next interim look will maybe be done mid-December at the earliest, if the 293rd patient can get their first dose around the first of November.
Quote:Question: Does the data review occur when the 293rd patient is enrolled (which is what the PR indicates), or is it when the 293rd patient reaches Day 28, or is it when the 293rd patient reaches Day 42?
DSMC also requests another data review when enrollment reaches 293 patients (75%)
Quote:Question: This sentence seems to confirm the notion that the data review occurs when the 293rd patient is enrolled -- but we have no confirmation.
The Company is working diligently to accelerate patient enrollment in the U.S. and U.K. to achieve the enrollment goal of 293 patients as quickly as possible (potentially in 4-6 weeks)
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